Development of Immunological Assays for the Evaluation of Tumor Antigen Specific Immunity

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
PX Biosolutions
ClinicalTrials.gov Identifier:
NCT02016833
First received: December 5, 2013
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

This study is a clinical study aiming at establishing immunological assays for the qualitative and quantitative evaluation of WT-1, Survivin and HPV16 E7-specific immune responses in cancer patients. Such a study will allow the development of suitable immunological tools to be used in assessing response in a subsequent phase I study aiming at evaluating therapeutic vaccine candidates targeting WT-1, Survivin and/or HPV16 E7-expressing tumors. In addition, this study will help defining the baseline cancer-associated immune responses in the selected patient population.

Cervical and ovarian cancer patients, as well as leukemia patients, will be included in this study.

WT-1, Survivin and HPV-specific immune responses will be monitored in these patients by ex vivo and cultured IFNg ELISpot as well as tetramer staining.


Condition Intervention
Ovarian Serous Adenocarcinoma
Undifferentiated Carcinoma of Ovary
Cervical Cancer
Cervical Intraepithelial Neoplasia, Grade 3
Acute Myeloid Leukemia
Chronic Myeloid Leukemia
Procedure: Blood Sampling

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Phase 0 Study for the Development of Immunological Assays for the Evaluation of WT-1, Survivin and HPV16 E7 Tumor Antigens Specific Immune Responses in Cancer Patients

Resource links provided by NLM:


Further study details as provided by PX Biosolutions:

Primary Outcome Measures:
  • Development and validation of ELISpot and tetramer assays for the detection of tumor-antigen specific T cell immune responses in cancer patients [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Direct and cultured IFNg ELISpot as well as direct tetramer staining assays will be set up and qualified for the detection WT-1, survivin and HPV16 E7 specific immune responses in cancer patients


Secondary Outcome Measures:
  • Characterisation of WT1, Survivin and HPV16 E7 specific immune responses in cancer patients [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Direct and Cultured IFNg ELISpot assays as well as tetramer staining assays will be used for the characterization of tumor specific immune responses in cancer patients


Biospecimen Retention:   Samples With DNA

PBMCs isolated from whole blood


Estimated Enrollment: 30
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cancer patients
Patient with histologically confirmed diagnosis of cervical cancer or cervical intraepithelial neoplasia (grade 3) or of high-grade serous (or undifferentiated) ovarian cancer or patients with AML or CML confirmed by bone marrow biopsy or peripheral blood Not treated - prior standard of care therapy acceptable one blood sampling performed on the visit day
Procedure: Blood Sampling
Sampling of 80mL of whole blood

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Three type of patients will be enrolled in this study:

  • Women with a confirmed diagnosis of serous or undifferentiated ovarian cancer
  • Women with a confirmed diagnosis of CIN3 or cervical cancer
  • HLA-A2 positive men or women with a confirmed diagnosis of AML of CML All these patients will be less than 70 years of age and will show no evidence of active progressive disease on follow up. For ovarian cancer patients, a woman with a rising CA125 and negative imaging is acceptable.
Criteria

Inclusion Criteria:

  • Specific Inclusion criteria
  • For ovarian cancer patients: Histologically confirmed surgical diagnosis of high-grade serous (or undifferentiated) ovarian cancer
  • For CIN3 and cervical cancer patients: Histologically confirmed diagnosis of CIN3 or cervical cancer
  • For AML and CML patients: HLA-A2 positivity and diagnosis of AML or CML confirmed by bone marrow biopsy or peripheral blood
  • Shared inclusion criteria
  • No evidence of active progressive disease. For ovarian cancer patients, a woman with a rising CA125 and negative imaging is acceptable
  • Age ≥ 18 yrs and < 70 yrs
  • ECOG 0-2
  • Adequate hematologic assessment (results from the previous standard of care visit):
  • Absolute neutrophil count (ANC) greater than or equal to 1.0 x 109/L
  • Platelets greater than or equal to 100 x 109/L.
  • Written informed consent

Exclusion Criteria:

  • Treatment with chemotherapy, radiation therapy, other immunotherapy or non-topical steroids within the past 3 weeks prior to initiation of the study.
  • Immunosuppressive therapy (excluding topical steroids) for any other condition.
  • Recurrent/progressive disease confirmed clinically, radiologically or histologically before entry into the study. (exclude versus inclusion criteria)
  • Persistent fever (>24 hours) documented by repeated measurement or active uncontrolled infection in the last 4 weeks.
  • Active autoimmune disease, including, but not limited to, SLE, MS, ankylosing spondylitis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02016833

Locations
Australia, Victoria
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
PX Biosolutions
Investigators
Principal Investigator: Linda Mileshkin, MD Peter MacCallum Cancer Centre, Australia
  More Information

No publications provided

Responsible Party: PX Biosolutions
ClinicalTrials.gov Identifier: NCT02016833     History of Changes
Other Study ID Numbers: PX_DCtagTM_LeadIn_001
Study First Received: December 5, 2013
Last Updated: March 4, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by PX Biosolutions:
Ovarian Cancer
Cervical Cancer
Leukemia
Immunity
WT-1
Survivin
HPV

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms
Carcinoma
Uterine Cervical Neoplasms
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Cystadenocarcinoma, Serous
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Neoplasms by Histologic Type
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Cystadenocarcinoma

ClinicalTrials.gov processed this record on August 18, 2014